Court Report – June 2015 #3

 About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al.
1:15-cv-00438; filed May 29, 2015 in the District Court of Delaware

• Plaintiff:  Mayne Pharma International Pty Ltd.
• Defendants:  Merck & Co., Inc.; Merck Sharp & Dohme Corp.; N.V. Organon

Infringement of U.S. Patent No. 6,881,745 (“Pharmaceutical Compositions for Poorly Soluble Drugs,” issued April 18, 2005) based on Merck’s manufacture and sale of its Noxafil® (posaconazole, used in the prophylaxis of fungal infections in immunocompromised patients, and in the treatment of oropharyngeal candidiasis).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Apotex, Inc. et al.
2:15-cv-03634; filed May 29, 2015 in the District Court of New Jersey

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Apotex, Inc; Apotex Corp.

Infringement of U.S. Patent No. 8,324,189 (“Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases,” issued December 4, 2012) following a Paragraph IV certification as part of Apotex’s filing of an ANDA to manufacture a generic version of Novartis’ Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC
2:15-cv-03654; filed May 29, 2015 in the District Court of New Jersey

Fresenius Kabi USA, LLC v. Innopharma Licensing, LLC et al.
2:15-cv-03655; filed May 29, 2015 in the District Court of New Jersey

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Innopharma Licensing, LLC; Innopharma Licensing, Inc.; Innopharma, LLC; Innopharma, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,006,689 (“Levothyroxine Formulations,” issued on April l4, 2015) following a Paragraph IV certification as part of Fera’s filing of an ANDA to manufacture a generic version of Fresenius’ Levothyroxine Sodium (levothyroxine sodium for injection, used to treat myxedema coma).  View the Fera complaint here.

Mylan Pharmaceuticals Inc. v. Janssen Pharmaceuticals, Inc.
2:15-cv-02990; filed May 29, 2015 in the Eastern District of Pennsylvania

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 8,629,179 (“Methods and Devices for Providing Prolonged Drug Therapy,” issued January 14, 2014) in conjunction with Mylan’s filing of an ANDA to manufacture a generic version of Alza’s Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the Delaware complaint here.  View the complaint here.

Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al.
1:15-cv-00430; filed May 28, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.

Infringement of U.S. Patent No. 5,763,476 (“Sublingual or Buccal Pharmaceutical Composition,” issued June 9, 1998) following a Paragraph IV certification as part of Amneal’s filing of an ANDA to manufacture a generic version of Forest’s Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder).  View the complaint here.

Warner Chilcott Co., LLC v. Amneal Pharmaceuticals LLC
3:15-cv-03590; filed May 28, 2015 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,667,050 (“Chewable Oral Contraceptive,” issued December 23, 2003) following a Paragraph IV certification as part of Amneal’s filing of an ANDA to manufacture a generic version of Warner Chilcott’s Minastrin® 24 Fe (ethinyl estradiol and norethindrone acetate, used for oral contraception).  View the complaint here.